Phase 2 · Liraglutide

NCT02443155 trial results

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Multi-centre Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function

Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to Baseline (Ratio of AUC), 0 - 4 hours post-dose on week 0 and week 54. NNC0114-0006 + Liraglutide (Experimental): 0.934; NNC0114-0006 (Experimental): 0.783; Liraglutide (Experimental): 0.709; Placebo (Placebo): 0.660.

Participants
308
Status
completed
Completed
2019-02-27
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02443155), updated at source Apr 9, 2021. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT02443155 measured first

Area Under the Concentration-time Curve (AUC) 0-4h of Mixed Meal Tolerance Test (MMTT) Stimulated C-peptide at Week 54 Relative to BaselineRatio of AUC · 0 - 4 hours post-dose on week 0 and week 54 · geometric mean
NNC0114-0006 + Liraglutide (Experimental)n=66NNC0114-0006 (Experimental)n=65Liraglutide (Experimental)n=68Placebo (Placebo)n=63
0.934(61.9)0.783(45.5)0.709(104.8)0.660(86.3)
Side effects by arm

Side effects in NCT02443155

Percent of participants affected, Weeks 0-80. The most common events the registry lists.

EventNNC0114-0006 + LiraglutideNNC0114-0006LiraglutidePlacebo
Any serious event9.1%6.5%11.8%14.3%
Nausea24.7%7.8%55.3%11.7%
Nasopharyngitis26%35.1%32.9%32.5%
Vomiting18.2%0%22.4%5.2%
Diarrhoea19.5%11.7%17.1%11.7%
Decreased appetite18.2%2.6%14.5%1.3%
Oropharyngeal pain13%16.9%6.6%11.7%
Influenza7.8%15.6%2.6%2.6%
Headache14.3%13%13.2%14.3%
Abdominal pain11.7%0%5.3%9.1%
Upper respiratory tract infection10.4%6.5%5.3%9.1%
Abdominal pain upper1.3%0%9.2%5.2%
Blood immunoglobulin E increased1.3%3.9%9.2%5.2%
Pyrexia3.9%9.1%9.2%5.2%
Fatigue5.2%5.2%7.9%2.6%
Cough7.8%5.2%6.6%1.3%
Gastroenteritis3.9%7.8%6.6%5.2%
Back pain1.3%5.2%6.6%2.6%
Dyspepsia6.5%3.9%3.9%5.2%
Lipase increased6.5%1.3%1.3%2.6%
Respiratory disorder5.2%2.6%0%6.5%
Respiratory tract infection viral6.5%1.3%3.9%2.6%
Rhinitis6.5%3.9%3.9%6.5%
Abdominal discomfort2.6%5.2%5.3%2.6%
Abdominal distension3.9%0%5.3%0%
Arthralgia5.2%1.3%1.3%3.9%
Secondary outcomes

What else it measured

AUC0-2h of C-peptide at Week 54 Relative to BaselineRatio of AUC · 0-2 hours post-dose on week 0 and week 54 · geometric mean
NNC0114-0006 + Liraglutide (Experimental)n=66NNC0114-0006 (Experimental)n=65Liraglutide (Experimental)n=68Placebo (Placebo)n=63
0.961(65.4)0.824(53.0)0.646(97.4)0.655(87.3)
Cmax of C-peptide at Week 54 Relative to BaselineRatio of Cmax · 0-4 hours post-dose on week 0 and week 54 · geometric mean
NNC0114-0006 + Liraglutide (Experimental)n=66NNC0114-0006 (Experimental)n=65Liraglutide (Experimental)n=68Placebo (Placebo)n=63
0.978(70.3)0.779(47.6)0.733(110.4)0.644(89.4)
AUC0-4h of Glucose at Week 54 Relative to BaselineRatio of AUC · 0 - 4 hours post-dose on week 0 and week 54 · geometric mean
NNC0114-0006 + Liraglutide (Experimental)n=65NNC0114-0006 (Experimental)n=65Liraglutide (Experimental)n=67Placebo (Placebo)n=62
0.904(33.1)1.078(31.8)0.993(34.2)1.089(36.7)
AUC0-2h of Glucose at Week 54 Relative to BaselineRatio of AUC · 0-2 hours post-dose on week 0 and week 54 · geometric mean
NNC0114-0006 + Liraglutide (Experimental)n=65NNC0114-0006 (Experimental)n=65Liraglutide (Experimental)n=67Placebo (Placebo)n=62
0.939(28.5)1.066(24.8)0.978(31.9)1.057(31.3)
Cmax of Glucose at Week 54 Relative to BaselineRatio of Cmax · 0-4 hours post-dose on week 0 and week 54 · geometric mean
NNC0114-0006 + Liraglutide (Experimental)n=65NNC0114-0006 (Experimental)n=65Liraglutide (Experimental)n=67Placebo (Placebo)n=62
0.937(27.8)1.068(25.4)1.004(29.1)1.057(30.9)
Number of Treatment Emergent Adverse EventsAdverse events · Week 0-54; Week 54-80 · number
MeasureNNC0114-0006 + Liraglutide (Experimental)n=77NNC0114-0006 (Experimental)n=77Liraglutide (Experimental)n=76Placebo (Placebo)n=77
Week 0-54434327410364
Week 54-8070737887
Number of Treatment Emergent Hyperglycaemic EpisodesEpisodes · Week 0-54; Week 54-80 · number
MeasureNNC0114-0006 + Liraglutide (Experimental)n=77NNC0114-0006 (Experimental)n=77Liraglutide (Experimental)n=76Placebo (Placebo)n=77
Week 0-54302256217291
Week 54-8030674352112
Number of Treatment Emergent Episodes of Diabetic KetoacidosisEpisodes · Weeks 0-54; Weeks 54-80 · number
MeasureNNC0114-0006 + Liraglutide (Experimental)n=77NNC0114-0006 (Experimental)n=77Liraglutide (Experimental)n=76Placebo (Placebo)n=77
Week 0-540000
Week 54-800011
Number of Participants Experiencing Treatment Emergent Injection/Infusion Site Reactions Caused by NNC0114-0006/Liraglutide/Placebo Injection/InfusionParticipants · Week 0-54 · count of participants
NNC0114-0006 + Liraglutide (Experimental)n=77NNC0114-0006 (Experimental)n=77Liraglutide (Experimental)n=76Placebo (Placebo)n=77
2001
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA)Episodes · Weeks 0-54; Weeks 54-80 · number
MeasureNNC0114-0006 + Liraglutide (Experimental)n=77NNC0114-0006 (Experimental)n=77Liraglutide (Experimental)n=76Placebo (Placebo)n=77
Severe hypoglycaemia (Week 0-54)1200
Asymptomatic hypoglycaemia (Week 0-54)2038195620921774
Documented symptomatic hypoglycaemia (Week 0-54)1305146111141625
Pseudo-hypoglycaemia (Week 0-54)11142
Probable symptomatic hypoglycaemia (Week 0-54)90410
Severe hypoglycaemia (Week 54-80)3101
Asymptomatic hypoglycaemia (Week 54-80)609522670449
Documented symptomatic hypoglycaemia (Week 54-80)514362651527
Pseudo-hypoglycaemia (Week 54-80)0012
Probable symptomatic hypoglycaemia (Week 54-80)1002
Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk DefinitionsEpisodes · Weeks 0-54; Weeks 54-80 · number
MeasureNNC0114-0006 + Liraglutide (Experimental)n=77NNC0114-0006 (Experimental)n=77Liraglutide (Experimental)n=76Placebo (Placebo)n=77
Severe or BG confirmed (Week 0-54)396394315503
Symptomatic BG confirmed (Week 0-54)576616479646
Severe or BG confirmed (Week 54-80)216130244240
Symptomatic BG confirmed (Week 54-80)368207332292
Change in Body Weight (kg)Kilogram (Kg) · (Week 0, week 54) and (week 0, week 80) · mean
MeasureNNC0114-0006 + Liraglutide (Experimental)n=77NNC0114-0006 (Experimental)n=77Liraglutide (Experimental)n=76Placebo (Placebo)n=77
Change from week 0 to week 54-1.8(4.2)1.2(5.0)-2.5(4.0)1.1(6.1)
Change from week 0 to week 801.9(4.6)1.6(5.2)0.4(4.7)2.8(5.5)
The trial

How NCT02443155 was run

This trial is conducted globally. The aim of this trial is to assess the clinical proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in adult subjects with newly diagnosed type 1 diabetes mellitus.

  • NNC0114-0006 + Liraglutide
  • NNC0114-0006 + Placebo
  • Liraglutide + Placebo
  • Placebo
Who could join the trial

Inclusion Criteria: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * T1DM (type 1 diabetes mellitus) (as diagnosed clinically) for not more than 20 weeks prior to screening - Male or female, aged 18-45 (both inclusive) at the time of signing the informed consent form * Non-fasting peak C-peptide higher or equal to 0.2 nmol/l at visit 2 * BMI (body mass index) higher or equal to 18.5 kg/m\^2 * Presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (GAD), islet antigen-2 (IA2) or zinc-transporter 8 (ZnT8)) at screening * Insulin dependence unless in temporary spontaneous remission (honeymoon period) Exclusion Criteria: * Daily insulin usage above 1 U/kg per day at screening or use of continuous subcutaneous insulin infusion (CSII) * History of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic infections or conditions predisposing to chronic infections (e.g., bronchiectasis and chronic osteomyelitis) * History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy * Vaccination within 4 weeks before randomisation, Visit 3 (V3) * Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening (V1) * History of pancreatitis (acute or chronic) * Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC) * Any past or current diagnosis of malignant neoplasms * Known impairment of the immune system, except for T1DM, coeliac disease, alopecia, autoimmune antibodies not considered clinical important (e.g. thyroid antibodies without any clinically important thyroid disease), and vitiligo

Published papers

Papers from NCT02443155

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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